Which document records the identity, purity, and strength of investigational products to be used in the trial?

• A. Shipping Records for Investigational Products and Trial-Related Materials
• B. Certificates of Analysis of Investigational Products Shipped
• C. Decoding Procedures for Blinded Trials
• D. Master Randomization List

Answer: (B)

Verifying the investigational product’s quality before use is essential, and the Certificate of Analysis serves exactly that purpose. It is the official document that records the product’s identity, purity, and strength (potency) by presenting the analytical test results for the batch. Along with details like the lot number, expiry date, and storage conditions, the CoA confirms the product meets its predefined specifications and is suitable for use in the trial. This document is used during batch release and for traceability to ensure the exact lot used in the study matches what was validated.

Shipping records show the movement and receipt of the product, but they do not certify its analytical characteristics. Decoding procedures pertain to blinding in trials, not product quality data. The master randomization list governs participant assignment, not the investigational product's quality attributes.